NCT04162483

Brief Summary

The objective of this retrospective study is to describe in real-life settings the clinical practice, utilization and the treated population outcomes at 1-year (12-16 months) follow-up at selected, representative centers in France.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
310

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 11, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 14, 2019

Completed
5 days until next milestone

Study Start

First participant enrolled

November 19, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2021

Completed
Last Updated

June 17, 2020

Status Verified

June 1, 2020

Enrollment Period

1.5 years

First QC Date

November 11, 2019

Last Update Submit

June 16, 2020

Conditions

Intracranial Aneurysm

Outcome Measures

Primary Outcomes (1)

  • permanent morbidity and mortality rate

    any major ipsilateral stroke or neurological death

    up to 12-16 months post-procedure

Secondary Outcomes (7)

  • AEs and device malfunctions

    peri-procedure

  • Efficacy Endpoint with mRS

    immediately post-procedure and at 12-16 months post procedure

  • Retreatment

    up to 12-16 months

  • Subarachnoid hemorrhage (SAH)

    Up to 12-16 months

  • Aneurysm rupture/re-rupture

    Up to 12-16 months

  • +2 more secondary outcomes

Interventions

Neuroform Atlas Stent SystemDEVICE

Stenting Assisted coiling procedure

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects treated in one of the French Sites participating to the registry and who have been treated with Neuroform Atlas for the treatment of intracranial aneurysm(s) between 01 February 2017 and 01 March 2018.

You may qualify if:

  • Patient who had undergone a stent assisted intracranial aneurysm coiling with Neuroform Atlas for the treatment of intracranial aneurysm(s) between 1st Feb 2017 and 1st March 2 018.
  • Patient and/or their representative have/has received the written information concerning the study and not expressed opposition to the collection of his data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Gui de Chauliac

Montpellier, F-34295, France

RECRUITING

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAneurysmVascular DiseasesCardiovascular Diseases

Study Officials

  • Emmanuel Houdart, MD

    Hopital Lariboisière

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Caroline Le Page, RN

CONTACT

+33678777761Caroline.lepage@stryker.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2019

First Posted

November 14, 2019

Study Start

November 19, 2019

Primary Completion

May 15, 2021

Study Completion

July 15, 2021

Last Updated

June 17, 2020

Record last verified: 2020-06

Locations

FR(1)